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Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)

K

King's College London

Status

Not yet enrolling

Conditions

Conversion Disorder With Weakness/Paralysis
Functional Neurological Disorder
Functional Neurological Disorders
Conversion Disorder

Treatments

Device: Brain-computer interface rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT07006415
TBC
349392

Details and patient eligibility

About

The purpose of this study is to determine whether a course of rehabilitation using a device called a brain-computer interface can change the level of control people feel over bodily movements, in functional neurological disorder.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • DSM5 diagnosis of motor FND (limb weakness, gait disorder, tremor or dystonia) from a neurologist and/or neuropsychiatrist.
  • Moderate or severe symptoms (≥4 on Clinical Global Impression Severity (CGI-S) scale).
  • Able to tolerate VR and BCI use.
  • Age 18 - 60 years.
  • English speaking.

Exclusion criteria

  • Current diagnosis of epilepsy, severe depression, bipolar disorder, psychotic disorder, personality disorder, or drug/alcohol dependence/harmful use (defined as meeting DSM-5 criteria) (Mini International Neuropsychiatric Interview [MINI] 7.0). Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
  • Current diagnosis of epilepsy, autistic spectrum disorder, dementia, learning disability (defined as meeting DSM-5 criteria) based on clinical interview by a psychiatrist.
  • A pacemaker, implantable cardioverter-defibrillator or any other implanted electronic or metallic device.
  • Current pregnancy.
  • Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
  • Those enrolled in another clinical or research study.
  • Those unable to give informed consent.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Brain-computer interface rehabilitation
Experimental group
Description:
Brain-computer interface rehabilitation
Treatment:
Device: Brain-computer interface rehabilitation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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